Technical Instructions
CERTIFICATION OF THE MANUFACTURER'S QUALITY ASSURANCE SYSTEM
These technical instructions provide basic information for obtaining a certificate, in accordance with theDirective 94/9/EC (ATEX 95), or per the requirements of the IECEx System
Agencija za prostore ugrožene eksplozivnom atmosferom – Ex-AGENCIJAHR-10001 Zagreb, Baštijanova bb, P.P. 304
Tel/Phone.: ++ 385 1 36 67 260 Fax.: ++ 385 1 36 67 262
/ PQC-TU-PRe/5
/ CERTIFICATION OF THE MANUFACTURER'S QUALITY ASSURANCE SYSTEM / /
1.INTRODUCTION
The purpose of these instructions is to clarify the procedure of certifying the quality assurance system of a manufacturer who produces equipment, components and systems intended for use in areas at risk of explosive atmospheres (gases, vapors, mist and dust). This procedure applies to the certification of the quality assurance system, based on Annexes IV and VII of the Directive 94/9/EC (ATEX 95), and the corresponding unified standards for quality assurance. The procedure of quality assurance assessment is specified in the IECEx System, based on publications IECEx 02, IECEx OD 005-1, IECEx OD 009, IECEx OD 025 and other appropriate documents (
In order to assess compliance with requirements of the Directive, harmonized European standards are used (e.g. EN ISO/IEC 80079-34 for quality assurance systems of Ex-equipment manufacturers).
These instructions do not contain the procedure of type certification (per Annex III of the Directive 94/9/EC which is described in the instructions on Equipment Certification (TU-CERT).
2.INITIAL, Surveillance AND RE-ASSESSMENT
The quality assurance certification by Ex-Agencija consists of: examination of the documentation (with regard to conformity and preparation for assessment), on-site assessment of the quality assurance system and elimination of any nonconformity ascertained. Once these nonconformities have been successfully eliminated within the given deadlines, a Quality Assurance notification is issued with an expiration date of 3 years, with mandatory surveillance assessment to be performed regularly. The quality assurance certification procedureis repeated before the certificate expires.
Ex-Agencijaprepares an audit program for independent on-site assessment of the quality assurance system. This program and the time necessary to implement it are determined according to the complexity and type of quality assurance system and the production plant, the number of type certificates and protection type applied, as well as any other relevant information (e.g. the existence of other certificates for the quality assurance system, or number of locations if production is carried out at various facilities). If there are several manufacturing locations, the assessment of the quality assurance system is implemented at those locations deemed necessary.
If the client wishes a revision or supplement to the area or scope of the certificate already issued, the client must submit a request in writing. Ex-Agencija will evaluate the request and notify the client within 14 days regarding approval/denial of the request, and specify the activities and deadlines necessary for completion of work.
The surveillance assessmentis performed according to the following schedule:
-annually, no more than 12 months apart, for quality assurance systems that are not certified or covered by standard ISO 9001 or
-no more than 18 months apart for quality assurance systems that are also certified by ISO 9001.
The surveillance and assessment involve evaluation of any changes in quality assurance documents and a control rating in the production plant. The purpose is to check the function of the system and its further compliance with the requirements of the quality assurance notification issued with an expiration date of 3 years.
Periodicre-assessment is performedaccording to the same procedure as the initial assessment, along with the results and remarks from previous inspections which are now taken into consideration.
3.SUBMITTING AN APPLICATION
To initiate the certification process, manufacturers or their authorized representatives in EU(for manufacturers outside EU) must fill out and submit form C-3-1 (available on Ex-Agencija’s website), which must bear the signature of a person authorized by the manufacturer or representative. The application is then assessed and if the inquiry is clear, the client is sent an offer and anAgreement. If the offer is acceptable the client submits an order and a signed copy of the Agreement, and sends documentation on the quality assurance system, as specified in Annexes IV and VII of the Directive 94/9/EC. Ex-Agencija confirms receipt of the order and initiates work.
The same form is used to submit a request for a supplemental certificate; that is, to expand the scopeof the certificate.
The client also accepts (as needed) the presence of a third-party observer during the assessment of the quality assurance system; e.g. assessors from the Croatian Accreditation Agency.
4.ASSESSMENT OF THE QUALITY ASSURANCE SYSTEM
The assessment of the quality assurance system is carried out in accordance with Annexes IV and VII of the Directive 94/9/EC, and standardEN ISO/IEC 80079-34. If the results are satisfactory at the end of the procedure, Ex-Agencija issues the client a Quality Assurance Notification marked EXA gg ATEX Qxxx. This notificationis issued with an expiration date of 3 years, under the condition that surveillance assessment are performed regularly.
Assessment of the quality assurance documentation
Ex-Agencija evaluates compliance (according to EHSrequirements or with the use of harmonizedstandards) of the quality assurance documentation with the Directive 94/9/EC. The quality assurance documentation should be written in either English or Croatian. The use of a third language can also be agreed upon if this is acceptable to both parties.
If during the examination the documents findany deficiency (which are, or may become nonconformities), the user is then notified of these findings, which should be clarified and/or eliminated before the on-site assessment.
On-site assessment of the quality assurance system of the client/manufacturer
After the documentation has been assessed, in agreement with the client Ex-Agencija prepares a program of on-site assessment at the client/manufacturer. The assessment program, as needed, can also include an on-site assessment of the supplier, who may be considered relevant to the explosion protection of Ex-equipment that the client intendto produce, in accordance with the Directive 94/9/EC.
The client may request exclusion of any member of the assessment team or ask changes to the schedule. If the client does not provide any objections to the program in writing, Ex-Agencija presumes the client has accepted the assessment programand members of the assessment team.
During the assessment Ex-Agencija observes implementation of the quality assurance system, and its compliance with the Directive 94/9/EC, EN ISO/IEC 80079-34 and other harmonizedstandards applied. The on-site assessment includes the following mandatory procedures:
-checking compliance with all requirements of regulations and standards applied,
-assessing the implementation of the quality assurance system, with regard to anticipated effects in accordance with the requirements of regulations and standards applied,
-assessing the quality assurance system with regard to legal requirements (e.g. the company's registration with the court),
-monitoring processes within the company,
-executing internal audits and management reviews,
-management's responsibility for the policy and objectives of quality assurance,
-any other legal, technical and standard requirements (for applicable types of protection) relevant to validating compliance of the existing quality assurance system.
At the end of the on-site assessment, an Assessment Report is prepared based on the data gathered and a meeting held with the client in which all findings, observations and conclusions are reviewed. The Assessment Report on the quality assurance system contains (minimally) the following:
a)date and place(s) of independent assessment,
b)names of assessment team members and persons present who represent the manufacturer and/or client,
c)the coverage for which the quality assurance assessment has been performed, including type of protection and type certificate,
d)notes on the compliance of quality assurance with the requirements of the Directiveand applied standards, with clear emphasis of any nonconformities and their detailed descriptions.
The Assessment Report is presented during the final meeting and signed by all parties present. Based on this report the client will, as needed, analyze causesand initiate corrective actions for any nonconformities determined, and inform Ex-Agencija accordingly.
If an additional assessment is conducted of the supplier considered to be relevant to the explosion protectionof Ex-equipment that the client wishes to produce, an additional Assessment Report is prepared.
Evaluating the results of system compliance and issuing the Notification
Once all nonconformities have been eliminated, Ex-Agencija evaluates compliance with the requirements. Based on the information gathered during the certification process and the repair activities performed, a decision is made regarding certification of the client's quality assurance system. If the corrective actionsare satisfactory, the decision is positive and a quality assurance notification are issued for the manufacture of equipment, components and systems intended for hazardous areas of gases, vapors, mist and dust.
If the results of the assessment do not comply with requirements, Ex-Agencija will notify the client accordingly, citing the reasons for denying issue of the certificate.
5.SUSPENSION, WITHDRAWAL AND COVERAGE REDUCTION OF THE QUALITY ASSURANCE NOTIFICATION
There are four main reasons for suspending a quality assurance notification:
-if Ex-Agencija determines that the manufacturer is not adhering to conditions stipulated in the agreement,
-if the quality assurance system does not continuously fulfill the requirements of legal regulations and applicable standards,
-if the client does not permit the performance of a surveillanceassessment or does not wish another reassessment,
-if the client requests a suspension of the certificate.
A notificationis temporarily invalid during suspension. If the notificationhas been suspended, per the Agreement the client is obligated to cease using the Ex-AgencijaNumberand discontinue all references to the Ex-Agencijanotificationin any advertising media. The suspension of the notificationwill be clearly indicated in the registry on Ex-Agencija’s website.
Ex-Agencija will request an explanation from the manufacturer and try to resolve any problems within a reasonable time-frame, but no longer than 6 months. In case an agreement cannot be reached, Ex-Agencija will, in accordance with the Agreement, withdraw the notification or reduce its coverage. Notification that have been withdrawn are deleted from the notification registry on
Ex-Agencija’s website.
In case the user or client does not return the original notification to Ex-Agencija, and the notification was issued for equipment that compromises the safety of the plant and the people in it, Ex-Agencija will inform the appropriate authorities.
If the user’s quality assurance system is only partially non-compliant with the requirements of regulations and standards, and the part in question can be excluded from coverage without significantly affecting the rest of the quality assurance system, Ex-Agencija can reduce the coverage of the notification to incorporate only those parts of the system that comply with regulations and standards.
6.OBJECTIONS AND COMPLAINTS
Any objections/complaints the client may have concerning the quality assurance notification issued, or any other unfavorable decision made by Ex-Agencija throughout the certification process, must be submitted to Ex-Agencija in writing. If the complaint is not in writing, Ex-Agencija will proceed in the manner it deems appropriate. Unfavorable decisions include:
-denial of applications,
-refusal to continue an assessment,
-requests for repair work,
-changes to the coverage of the quality assurance notification,
-denial, suspension or withdrawal of the quality assurance notification
-any other activities that prevent the client from acquiring and/or maintaining the quality assurance notification
Ex-Agencija will process the objections/complaints according to procedure B-15, which can be provided on request.The complainant will be notified of Ex-Agencija’s position on the matter in writing. Ex-Agencija will attempt to resolve the issues by agreement within a reasonable time-frame, but no longer than 30 days. If the objection/complaint has not been resolved in a positive manner, the client may submit an appeal to the appropriate authority.
Before a decision is reached, the information in the complaint is reviewed and analyzed, and the client is informed of the results in writing. Records are kept on all complaints and actions implemented.
Any person or organization can express dissatisfaction to Ex-Agencija (where a response is expected) regarding its activities or the activities of the manufacturer whose quality assurance system has been certified by Ex-Agencija.
Ex-Agencija will assess the significance of the complaintand, if the complaint is justified, undertake the appropriate actions needed. The procedure of handling complaints is considered to be strictly privileged information, for the protection of both the complainant and Ex-Agencija clients.
If the complaint is not in writing, or is received from an unidentified source, Ex-Agencija will proceed in the manner it deems appropriate. If such need is indicated, Ex-Agencija will (with the permission of the complainant and the client) stipulate the conditions under which the content and resolution of the complaint may become public information. Ex-Agencija will attempt to resolve the issues by agreement within a reasonable time-frame, but no longer than 30 days.
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